This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cord
FDA device recall Z-0909-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Air may be introduced into this Stent system when used with certain size acessory devices.
- Action taken
- On Jan. 13, 2004 Cordis initiated Sales Representative visits to accounts to provide enhanced Instructions for Use to prevent the air introduction problem which was followed by a Recall Letter to each account providing corrective Instructions for Use on March 29, 2004. Another letter issued on May 4, 2004 recalling the earlier March 29, 2004 letter and modified Instructions for Use, instructing consignees/physicians to only use the device in the biliary tree or liver as indicated in the lableling.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 7815
- Distribution
- Product was distributed to 415 domestic hospital accounts nationwide and to two related international distributores in Isreal and the Netherlands.
- Date initiated
- 2004-01-13
- Date posted
- 2004-07-20
- Date terminated
- 2010-08-30
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K032137) | Cordis Corp. | 2003-09-17 |